Phase 2 Study to Evaluation the Safety and Efficacy of Orally Administered KL7016 in Patients With Dry Eye Syndrome

Dry Eye Syndrome Clinical Trial

Official title:

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, 12 Weeks, Phase II Clinical Study to Evaluate the Safety and Efficacy of Orally Administered KL7016 in Patients With Dry Eye Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02092207
• Other study ID #: KL7016_201
• Status: Completed
• Phase: Phase 2
• First received: March 17, 2014
• Last updated: December 19, 2017
• Start date: October 2012
• Est. completion date: July 2014

Study information

• Verified date: December 2017
• Source: Yungjin Pharm. Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a controlled study to determine the effectiveness and safety of KL7016 in the treatment of adult patients with dry eye syndrome (DES).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 147
• Est. completion date: July 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Corneal staining score of =5 in either eye by the National Eye Institute/Industry Workshop guidelines

• Schirmer test score (without anesthesia) < 7 mm/5 min in either eye

• Willing to use no topical ocular treatments, other than REFRESH TEARS® for the duration of the trial

Exclusion Criteria:

• Intraocular surgery within 3months

• Persistent intraocular inflammation or infection

• Corneal transplantation or neurotrophic keratitis

• Stevens-Johnson Syndrome

• Ocular herpes simplex virus infection

• Concomitant use of contact lenses or use within 3months

• Silicone lacrimal punctal occlusion or cauterization of the punctum within 3months

• Vision correction surgery without DES within 12months

• Unstable use of methotrexate or Disease-modifying drugs

Related Conditions & MeSH terms

• Dry Eye Syndrome
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca
• Syndrome

Intervention

Drug:
• KL7016 900mg
oral administration, 150mg 3tab, bid
• KL7016 600mg
oral administration, 150mg 3tab, bid
• Placebo
oral administration, 150mg 3tab, bid

Locations

Country	Name	City	State
Korea, Republic of	Chonnam National University Hospital	Gwangju	Jebong-ro, Dong-gu
Korea, Republic of	Seoul National University Bundang Hospital	Gyeonggi-do	Gumi-ro 173 Beon-gil Bundang-gu
Korea, Republic of	ASAN Medical Center	Seoul	Olympic-ro 43-gil, Songpa-gu
Korea, Republic of	Gangnam Severance Hospital	Seoul	Eonju-ro, Gangnam-gu
Korea, Republic of	Konkuk University Medical Center	Seoul	Neungdong-ro, Gwangjin-gu
Korea, Republic of	Korea University Guro Hospital	Seoul	Gurodong-ro, Guro-gu
Korea, Republic of	Samsung Medical Center	Seoul	Irwon-ro, Gangnam-gu
Korea, Republic of	Severance Hospital	Seoul	Yonsei-ro, Seodaemun-gu
Korea, Republic of	The Catholic University of Korea, Seoul St. Mary's Hospital	Seoul	Banpo-daero, Seocho-gu

Sponsors (1)

Lead Sponsor	Collaborator
Yungjin Pharm. Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in corneal staining score		baseline, 12 weeks
Secondary	Change in schirmer test score		baseline, 4weeks, 8weeks, 12 weeks
Secondary	Change in OSDI(Ocular Surface Disease Index)		baseline, 4weeks, 8weeks, 12 weeks
Secondary	Change in TFBUT(Tear Film Break-up Time)		baseline, 4weeks, 8weeks, 12 weeks
Secondary	Change in conjunctival staining score		baseline, 4weeks, 8weeks, 12 weeks
Secondary	Change in corneal staining score		baseline, 4weeks, 8weeks